Tuesday, September 2, 2025

Trump's Push To Shore Up Pharma Supply Chain With US API Welcomed But Questioned

(9/2, Nick Paul Taylor, BioSpace) ...The analysts predicted that if forced to act, "API suppliers will selectively on-shore products under mandate but demand economically feasible contracts and longevity." Limiting their analysis to companies they cover, Sulewski and Larson said ANI Pharma, Amneal Pharmaceuticals, Bausch Health and Teva Pharmaceuticals could face "some potential disruption." The analysts wrote that the impact "should be manageable." Teva has "by far the largest API and generics exposure" among the companies Truist covers, they continued.. However, the company could reduce its exposure if the proposed divestiture of its API business goes ahead... Full

Trump Plans a Hefty Tax On Imported Drugs, Risking Higher Prices and Shortages

(9/1, Paul Wiseman and Tom Murphy, Associated Press) ..."Shock and awe'' is how Maytee Pereira of the tax and consulting firm PwC describes Trump's plans for drugmakers. "This is an industry that's going from zero (tariffs) to the potentiality of 200%.''..."A tariff would hurt consumers most of all, as they would feel the inflationary effect ... directly when paying for prescriptions at the pharmacy and indirectly through higher insurance premiums,'' Diederik Stadig, a healthcare economist with the financial services firm ING, wrote in a commentary last month, adding that lower-income households and the elderly would feel the greatest impact... Full

Tariffs, Pharma, and Patients: A Q&A with Orr Inbar

(9/1, Nicole Raleigh, Pharmaphorum) ...The threat of tariffs has loomed over countries and industries alike during Trump's second administration. But with a potential 200% tariff on pharmaceutical imports into the US – which could affect ~$200 billion in imports – the life sciences sector has been rightly unsettled, forcing many drug developers to reconsider and adjust their business strategies...In order to discuss this current and as yet unsettled landscape further, and just how these tariffs might affect patients themselves, pharmaphorum spoke with Orr Inbar, CEO and co-founder of QuantHealth... Full

Trump Calls On Pharmaceutical Companies to Justify Success of COVID Drugs

(9/1, Jasper Ward, Reuters) ...He said there is disagreement on whether the drugs saved lives. "With CDC being ripped apart over this question, I want the answer, and I want it NOW," Trump wrote on Truth Social. "I have been shown information from Pfizer, and others, that is extraordinary, but they never seem to show those results to the public."... Full

House Oversight Committee Presses PBMs On GPOs

(9/2, NCPA) ...[Rep. James Comer (R-Ky.)] noted that GPOs "appear to be yet another example of the institutional intent at opacity and avoidance of oversight within your company ... the committee is concerned that your company's opaque business practices and relationships, including the creation of new corporate structures abroad, combined with unchecked integration, is hurting patients and costing taxpayers." Comer requested that the companies disclose a range of materials to the committee about how these subsidiaries operate... Full

FTC and Congressional Oversight Leader Take Aim at PBMs Again

(8/29, Zachary Brennan, Endpoints News) ...A CVS spokesperson said in a statement on the suit, "CVS Health is confident the facts are on our side – drugmakers alone set the price of insulin – and we will continue to defend the case vigorously to protect our ability to make insulin affordable for American consumers and businesses."...A spokesperson for the association representing PBMs, known as the Pharmaceutical Care Management Association, told Endpoints News in a statement, "The committee's continued focus solely on PBMs misses the mark and will do nothing to lower drug costs. Drug prices, set solely by drug companies, are the root cause of high drug costs."... Sub. Req’d

Petition To FDA Could Stall Generic Ozempic, Force Position On Device-Hopping

(8/29, Maaisha Osman, Inside Health Policy) ...A law firm representing a little-known Dubai-based company with no clear ties to the diabetes or weight-loss drug markets has petitioned FDA to delay approval of generic versions of Novo Nordisk's blockbuster drug Ozempic, alleging injector-device and manufacturing risks. Access-to-medicines advocates say the delay could stall cheaper alternatives for years if the agency doesn't take a position against so-called device-hopping in the Orange Book... Sub. Req’d

U.S. Biosimilar Market Entry Challenges and Facilitating Factors

(8/29, ASPE) ...The estimated savings to the U.S. healthcare system from the use of biosimilars are significant. However, there is limited research on the cost of biosimilar development, expected market uptake for biosimilar entrants, barriers that may affect market entry decisions, and potential incentives to encourage market entry. This study aims to fill these gaps by evaluating potential biosimilar development policy changes... Full

US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

(9/1, Derrick Gingery, Pink Sheet) ...GDUFA negotiations are expected to start in mid-October, followed by PDUFA negotiations in November. During the last renewal cycle, negotiations for both programs started in September and lasted several months. Sources said that the White House and HHS have not indicated they want to be involved in the talks, which will determine the fate of more than $2bn in annual user fee revenue... Global Sub. Full

Maryland PDAB Dossiers For Ozempic, Trulicity Accepting Comments

(8/29, Luke Zarzecki, Inside Health Policy) ...The Maryland Prescription Drug Affordability Board (PDAB) is requesting comments on its dossiers for Novo Nordisk's Ozempic and Eli Lilly's Trulicity by Sept. 4, asking whether the two drugs have created unaffordability challenges for the state's health care system; neither company is confirming plans to work with the board on a key concern... Sub. Req’d

Eisai Secures FDA Green Light for Leqembi Autoinjector, Teeing Up At-Home Maintenance Dosing

(8/29, Fraiser Kansteiner, Fierce Pharma) ...IQLIK's approval could be a "game changer" in Alzheimer's treatment, Katsuya Haruna, senior group officer and executive vice president of U.S. business operations at Eisai, said in an interview with Fierce Pharma, noting that the 15-second injection is now the first and only amyloid therapy that can be administered at home. The do-it-yourself benefit could be especially meaningful for patients in rural areas who may have trouble reaching infusion centers, and it could free up more infusion capacity at those centers in parallel, he added... Full

Teva Brings First Generic GLP-1 to US Market with Saxenda Copycat Approval

(8/29, Annabel Kartal Allen, Pharmaceutical Technology) ...Teva's subcutaneous medication can now be administered in adult patients who are overweight or obese and have weight-related comorbidities. It is also suitable for obese patients aged between 12 and 17 years who weigh more than 60kg. This marks Teva's fifth first-to-market entry for a generic product this year, according to SVP and head of US commercial generics Ernie Richardsen... Full

Vanda Slams US FDA ‘Generic Bias,' Again Seeks To Undo Hetlioz ANDA Approvals

(9/1, Dave Wallace, Pink Sheet) ...Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals in its latest bid to thwart generic competition for Hetlioz (tasimelteon). Claiming an "unacceptable culture of bias toward approving generic drugs" at the FDA, Vanda criticized former Acting CDER Director Jacqueline Corrigan-Curay in connection with an earlier decision on generics from Teva and MSN. Vanda also slammed "FDA bureaucrats" for suggesting the commissioner's office would take two months to decide whether it would review the decision, saying "it is time that the rule of law return to the FDA under Dr. Makary's leadership."... Global Sub. Full

Xbrane Sees SEK1Bn Annual Upside From Intas-Partnered Opdivo Biosimilar

(9/1, Dean Rudge, Generics Bulletin) ...Based on internal estimates, Xbrane Biopharma anticipates generating over SEK1bn ($105m) annually from its nivolumab biosimilar, Xdivane, which is partnered with Intas. The Swedish player has highlighted Intas's initiation of a clinical trial enrolling 340 melanoma patients, developed with insights from both the EMA and FDA. Xbrane is optimistic about being one of four US biosimilars available as Opdivo's US patent expires in 2028, projecting a maximum market share of 19%... Global Sub. Full

US Food and Drug Administration (FDA) Approves Henlius and Organon's BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively

(9/2, Organon, Henlius) ...Shanghai Henlius Biotech, Inc., and Organon today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products... Full

Polpharma Biologics and MS Pharma Sign Licensing Agreements for Proposed Vedolizumab (PB016), Ocrelizumab (PB018) and Guselkumab (PB019) Biosimilars

(9/2, Polpharma Biologics) ...Under the agreements, MS Pharma will be responsible for the registration, marketing, and distribution of these three biosimilars across MENA, while Polpharma Biologics will maintain responsibility for development, manufacturing, and supply. Furthermore, both Parties have agreed to transfer fill and finish activities to the MENA region. These operations will be carried out at MS Pharma's first of its kind biologics manufacturing facility in Saudi Arabia... Full

Celltrion Gets EMA Nod for Phase 3 Trial of Darzalex Biosimilar

(9/1, Kim Ji-hye, Korea Biomedical Review) ...Celltrion said Monday it has received European Medicines Agency approval to begin a phase 3 trial of CT-P44, its biosimilar to Johnson & Johnson's Darzalex Faspro (daratumumab and hyaluronidase-fihj), in relapsed or refractory multiple myeloma...Celltrion said the authorization, granted last Friday, covers Part 2 of the EMA's revised clinical trial process. The company aims to use the results to confirm CT-P44's efficacy and safety as a biosimilar... Full

Glenmark Pharma Arm to Launch Breast Cancer Treatment Injection in US Market

(9/2, CNBC TV-18) ...The product is therapeutically equivalent to Eisai Inc.'s Halaven in the same dosage strength of 1 mg/2 mL (0.5 mg/mL), a widely prescribed oncology drug for the treatment of breast cancer, the company said in a stock exchange filing on Tuesday. Distribution of the drug will commence in September 2025. The launch marks a key milestone for Glenmark as it represents the company's first complex generic product in the US institutional segment... Full

CapVest Buys German Drugmaker Stada in €10Bn Private Equity Deal

(9/1, Ivan Levingston and Florian Müller, Financial Times) ...Stada, which sells generic drugs and consumer health products, was delisted from the Frankfurt stock exchange in 2017 by the buyout investors Bain Capital and Cinven for €5.3bn. The two groups had been exploring options for Stada, including an initial public offering, and will retain a minority stake in the company following CapVest's takeover, according to a statement on Monday... Full

Stada Changes Hands As CapVest Takes Control

(9/1, Dave Wallace, Generics Bulletin) ...After a long period during which Stada and its current owners Bain Capital and Cinven have hinted at a change in ownership – with several suggestions both earlier this year and more recently that an initial public offering could be imminent – a deal has now been announced that will see international private equity investor CapVest acquire a majority stake in the German generics, biosimilars and consumer healthcare giant, with the new owner promising to "deploy significant new capital" to advance Stada's interests... Global Sub. Full

AstraZeneca Aims for 2025 Filing With What it Calls 'Best-in-Class' Hypertension Pill, But Will Likely Face Competition

(8/30, Elizabeth Cairns, Endpoints News) ...The three-month blood pressure data presented Saturday showed a strong effect in patients with uncontrolled or resistant hypertension, forms of high blood pressure that do not respond to standard treatment. Patients given the higher dose of baxdrostat in the trial, 2 mg per day, had an absolute reduction in average seated systolic blood pressure of 15.7 mmHg at three months. Adjusted for placebo, the decrease was 9.8mmHg...But the BaxHTN results appear to lag behind a rival product from Mineralys Therapeutics at the same time point. Mineralys' pill lorundrostat demonstrated a statistically significant placebo-adjusted blood pressure drop of 11.7 mmHg after three months' treatment in its pivotal study, with a 50 mg-per-day dose... Full

Novo Nordisk's Wegovy Cuts Heart Risk by 57% Versus Rival Lilly Weight-Loss Drug in Study

(8/31, Gursimran Kaur, Reuters) ...Novo Nordisk said on Sunday its blockbuster weight-loss drug Wegovy cut the risk of heart attack, stroke or death by 57% versus Eli Lilly's rival medicines Mounjaro and Zepbound in a real-world comparison of overweight and obese patients with cardiovascular disease but not diabetes... Full

Lilly Terminates Two Phase 2 Studies of Next-Gen Oral GLP-1 Drug

(8/29, Kyle LaHucik, Endpoints News) ...Lilly confirmed the ending of the trials, but declined to share any further details, beyond noting that it's still in a Phase 2 in adults with obesity that should end next year. Results from that study "will inform the next steps for this program," a spokesperson said in an email. Lilly and its biggest competitor, Novo Nordisk, have been looking for their next franchises in weight management and diabetes. Lilly is expected to ask for regulatory approval of its first oral obesity medicine, the GLP-1 dubbed orforglipron, by the end of this year. Novo, meanwhile, expects an FDA approval decision on the oral version of Wegovy in the fourth quarter... Full

How Novo Nordisk Failed to Protect its GLP-1 Patent

(9/1, Luke McDonagh, Financial Times) ...Novo Nordisk's frustration is understandable. Despite holding a portfolio of patents on semaglutide, its IP arsenal has proven surprisingly ineffective. The enforcement problem is structural. Unlike taking action against generic manufacturers — which are typically large-scale operations, Novo must prove its rights are being infringed by independent compounding pharmacies scattered across the US... Sub. Req’d

Does a Common Heart Attack Pill Help Everyone? Studies Disagree

(8/30, Nancy Lapid, Reuters) ...Most important, [Dr. Borja Ibanez] said, is the finding both teams agree on, which is that beta-blockers reduce the combined risk of another heart attack, heart failure, or death in patients without heart failure but with mildly impaired heart function. The question is whether the pills are beneficial or useless for those with normally functioning hearts, who account for about 80% of patients after a first heart attack. Beta-blocker manufacturers include Mylan, Novartis, Pfizer, Abbott, Teva Pharmaceutical Industries, Amneal Pharmaceuticals, Sun Pharmaceutical Industries, Lupin, ANI Pharmaceuticals, and Eagle Pharmaceuticals... Full

Aurobindo Pharma API Plant Gets 5 Observations from FDA

(9/1, ETPharma.com) ...Aurobindo Pharma wholly owned subsidiary Apitoria Pharma's API facility in Telangana, has received a form 483 with five observations from the US Food and Drugs Administration...Without disclosing the nature of observations the company stated that the observations are procedural in nature and "no data integrity issues were reported."... Full

MHRA Backs Global AI Framework For Pharmacovigilance Over UK-Specific Guidance

(8/29, Vibha Sharma, Pink Sheet) ...The UK's medicines regulator, MHRA, has shifted its focus from developing its own standalone AI guidance for pharmacovigilance to using international standards developed by the Council for International Organizations of Medical Sciences...Earlier this year, Teva said it was developing a ChatGPT-based tool for pharmacovigilance to help summarize literature articles. The move was aimed at reducing manual labor, as the company's large portfolio requires reviewing and summarizing over 250 articles a month. Teva began using AI in 2022 to automate the literature signal detection process, and in 2023 expanded its use to include searching for labeling lists on external websites. In 2024, it automated the adverse event triage process in literature and the triage process within its own safety mailbox... Global Sub. Full

New UK Network Targets Speed And Inclusion For Commercial Clinical Trials

(9/1, Vibha Sharma, Pink Sheet) ...The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service... Global Sub. Full

SANT Committee Prioritises Manufacturing Competitiveness in Draft Report On the Critical Medicines Act

(9/1, Medicines for Europe) ...The report pushes strongly to improve the competitiveness of the EU pharmaceutical manufacturing sector and better coordination of contingency stocks as additional objectives of the Regulation. It also expands the Act's scope by broadening the definition of medicinal product of common interest and making the Investments Chapter also applicable to such medicinal products, as well as to critical medicines. Medicines for Europe is committed to Europe's health security and supports an ambitious Critical Medicines Act... Full

EU Draft Report Sharpens Focus On Security and Manufacturing

(9/2, The Pharma Letter) ...The draft expands the Act's scope by broadening the definition of "medicinal product of common interest" and extending investment incentives beyond critical medicines. It also proposes a one-stop shop for strategic projects, designed to give manufacturers quicker access to funding, technical support and regulatory flexibility. Stockpiling rules would be toughened under the plan, with stricter solidarity requirements across member states, enhanced Commission oversight of stock levels, and mandatory reporting... Sub. Req’d

EMA and WHO Mark Ten Years of Collaboration to Advance Global Access to Medicines

(9/1, European Medicines Agency) ...EMA and the World Health Organization (WHO) are celebrating a decade of formal collaboration and shared commitment to address global health challenges. Since the signing of a confidentiality arrangement in September 2015, their partnership has focused on cooperation on scientific evaluation, capacity building, enhancing regulatory efficiency to contribute to public health worldwide... Full

Pharmacist Warned for Dispensing Generics Amid ‘Lack of Supply'

(9/2, Molly Bowcott, C+D) ...Christian Charles Logue, registration number 2046252, has received a warning after he was found to have substituted branded prescription medicines for generic versions of the drugs, the General Pharmaceutical Council (GPhC) revealed. In a hearing on August 18-20, a fitness-to-practise (FtP) committee heard that he "failed to provide person-centred care" by "dispensing generic medicines instead of the prescribed branded versions"... Full

How Europe Can Harness the Full Potential of Biosimilars

(9/2, Elena Wolff-Holz, Pharmaphorum) ...Streamlining biosimilars' development by forgoing unnecessary phase three trials will enhance patient access to essential medicines, optimise resource allocation, and free up space for innovation. As healthcare systems grapple with financial and operational pressures, making the clinical development process more efficient is vital to unlocking the full potential of biosimilars and promoting financially sustainable healthcare for all... Full

Irish Pharma Risks Hostage Situation as EU Weighs DSA and Ukraine Criticism

(8/31, Brian Maguire, Euractiv) ...The Irish Foreign Minister, Simon Harris, met virtually this week with United States Trade Representative Ambassador Jamieson Greer. The meeting on August 26, was held just as tensions emerged between Washington and Brussels over digital rights and the Ukraine war. Following the meeting, Euractiv spoke with Fine Gael TD Colm Burke, representing the pharma-centric constituency of Cork North Central..."What the Agreement does is avoid a harmful tariff-escalation across the Atlantic and ensures continued access to American markets," said Burke, "It provides stability and predictability for Irish exporters in an exceptional situation where the United States is imposing high tariffs on imports from countries around the world," he told Euractiv... Full

Chinese Companies Turn to Generics as Shipments Behind US Weight-Loss Craze Fade

(9/2, Patrick Wingrove, Reuters) ...Cheap copies of Wegovy and Eli Lilly's Zepbound are on the retreat in the U.S. as regulators restrict their sale, slowing shipments from Chinese suppliers of the raw ingredients that allowed for explosive growth of the medicines...At least eight Chinese companies, including publicly traded Jiangsu Sinopep-Allsino Biopharmaceutical and Hybio Pharmaceutical, helped flood the U.S. with raw semaglutide and tirzepatide, the main ingredients in Wegovy and Zepbound, respectively, sources told Reuters. A Reuters analysis of U.S. FDA shipping records backs that up... Full

Brazil & Mexico Bet On Regulatory Reliance To Improve Pharmacovigilance & Access To Medicines

(9/1, Francesca Bruce, Pink Sheet) ...Mexico's COFEPRIS and Brazil's ANVISA have signed a memorandum of understanding to expand regulatory reliance and information exchanges. Areas of interest for the regulators include regulatory authorization of health care products and pharmacovigilance. Regulatory reliance can help expand trade between the two countries and improve access to medicines, says ANVISA... Global Sub. Full

Italy and Egypt Strengthen Cooperation On Pharma

(9/1, The Pharma Letter) ...A recent institutional meeting took place in Cairo between Egypt's Deputy Prime Minister and Minister of Health and Population, Khaled Abdel Ghaffar, and the president of Italian trade group Farmindustria, Marcello Cattani...The discussions focused on cooperation between Italy and Egypt aimed at developing joint investments by pharmaceutical companies, technology transfer, and the localization of drug and vaccine production in Egypt, as well as the availability in Egypt of orphan drugs and products resulting from Italian research, in response to domestic market needs and with a view to export to regional and international markets... Sub. Req’d

India Eyes Russia, Brazil, Netherlands for Pharma Export Growth as US Tariffs Concerns Linger

(9/2, Rishika Sadam, Reuters) ...India plans to increase pharmaceutical exports to Russia, the Netherlands and Brazil, according to two industry sources aware of the matter, aiming to expand its presence beyond the United States, its largest market, amid tariff-related concerns...The Indian government has been in talks with pharmaceutical groups to focus on increasing UK exports following a free trade agreement with the country. India is expecting a "significant boost" in procurement of generics and active pharmaceutical ingredients by the UK's National Health Service, according to government data... Full

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